Elekta Recalls

Hazard: Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.

Hazard: Incorrect Dose when using the reset function.

Hazard: When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.

Hazard: There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.

Hazard: In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.

Hazard: Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.

Hazard: It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.

Hazard: It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.

Hazard: When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.

Hazard: If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.

Hazard: The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.

Hazard: When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.

Hazard: Incorrect drug dosage due to "Age Limit" and patient weight data item issue.

Hazard: First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.

Hazard: Unintended update of Dose and MU and Incorrect Assignment of Bolus.

Hazard: Incorrect Treatment Delivery Using Third Party Fixed Wedges.

Hazard: Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.

Hazard: A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.

Hazard: Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.

Hazard: Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

Hazard: It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenance. Clinical mistreatment may occur if a position error is not detected.

Hazard: Incorrect CT to ED when using the Monaco Image Statistics Tool.

Hazard: Incorrect CT to ED when using the Monaco Image Statistics Tool.

Hazard: Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.

Hazard: A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.

Hazard: Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.

Hazard: Incorrect Delivery of Composite VMAT Fields - When DICOM is exporting an arc plan (VMAT, Dynamic Conformal or 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.

Hazard: When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved treatment plan.

Hazard: MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.

Hazard: A bug in the software prevents the iGUIDE software from logging off.